PMID- 33412562
OWN - NLM
STAT- MEDLINE
DCOM- 20210423
LR  - 20210423
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 1
DP  - 2021
TI  - Personalized treatments for depressive symptoms in patients with advanced heart 
      failure: A pragmatic randomized controlled trial.
PG  - e0244453
LID - 10.1371/journal.pone.0244453 [doi]
LID - e0244453
AB  - OBJECTIVES: Heart Failure is a chronic syndrome affecting over 5.7 million in the 
      US and 26 million adults worldwide with nearly 50% experiencing depressive 
      symptoms. The objective of the study is to compare the effects of two 
      evidence-based treatment options for adult patients with depression and advanced 
      heart failure, on depressive symptom severity, physical and mental health related 
      quality of life (HRQoL), heart-failure specific quality of life, caregiver 
      burden, morbidity, and mortality at 3, 6 and 12-months. METHODS: Trial design. 
      Pragmatic, randomized, comparative effectiveness trial. Interventions. The 
      treatment interventions are: (1) Behavioral Activation (BA), a patient-centered 
      psychotherapy which emphasizes engagement in enjoyable and valued personalized 
      activities as selected by the patient; or (2) Antidepressant Medication 
      Management administered using the collaborative care model (MEDS). Participants. 
      Adults aged 18 and over with advanced heart failure (defined as New York Heart 
      Association (NYHA) Class II, III, and IV) and depression (defined as a score of 
      10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric 
      Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical 
      Center who are admitted with heart failure and all patients presenting to the 
      outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. 
      We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to 
      follow-up/inability to collect follow-up data. Thus, we plan to include 150 in 
      each group for a total of 300 participants from which data after randomization 
      will be collected and analyzed. CONCLUSIONS: The current trial is the first to 
      compare the impact of BA and MEDS on depressive symptoms, quality of life, 
      caregiver burden, morbidity, and mortality in patients with depression and 
      advanced heart failure. The trial will provide novel results that will be 
      disseminated and implemented into a wide range of current practice settings. 
      REGISTRATION: ClinicalTrials.Gov Identifier: NCT03688100.
FAU - IsHak, Waguih William
AU  - IsHak WW
AUID- ORCID: 0000-0003-1970-4756
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
AD  - David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of 
      America.
FAU - Korouri, Samuel
AU  - Korouri S
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Darwish, Tarneem
AU  - Darwish T
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Vanle, Brigitte
AU  - Vanle B
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Dang, Jonathan
AU  - Dang J
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Edwards, Gabriel
AU  - Edwards G
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Black, Jeanne T
AU  - Black JT
AD  - Division of Health Services Research, Department of Medicine, Cedars-Sinai 
      Medical Center, Los Angeles, CA, United States of America.
FAU - Aronow, Harriet
AU  - Aronow H
AD  - Division of Health Services Research, Department of Medicine, Cedars-Sinai 
      Medical Center, Los Angeles, CA, United States of America.
FAU - Kimchi, Asher
AU  - Kimchi A
AD  - Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.
FAU - Spiegel, Brennan
AU  - Spiegel B
AD  - David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of 
      America.
AD  - Division of Health Services Research, Department of Medicine, Cedars-Sinai 
      Medical Center, Los Angeles, CA, United States of America.
AD  - UCLA Fielding School of Public Health, Los Angeles, CA, United States of America.
FAU - Hedrick, Rebecca
AU  - Hedrick R
AUID- ORCID: 0000-0002-3692-8826
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Chernoff, Robert
AU  - Chernoff R
AUID- ORCID: 0000-0003-2470-0610
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Diniz, Marcio A
AU  - Diniz MA
AD  - Biostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, 
      United States of America.
FAU - Mirocha, James
AU  - Mirocha J
AD  - Biostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, 
      United States of America.
FAU - Manoukian, Vicki
AU  - Manoukian V
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
FAU - Harold, John
AU  - Harold J
AUID- ORCID: 0000-0001-6475-4002
AD  - Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.
FAU - Ong, Michael K
AU  - Ong MK
AD  - David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of 
      America.
AD  - UCLA Fielding School of Public Health, Los Angeles, CA, United States of America.
AD  - VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of 
      America.
FAU - Wells, Kenneth
AU  - Wells K
AUID- ORCID: 0000-0002-7454-6589
AD  - David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of 
      America.
AD  - UCLA Fielding School of Public Health, Los Angeles, CA, United States of America.
AD  - VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of 
      America.
FAU - Hamilton, Michele
AU  - Hamilton M
AD  - Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.
FAU - Danovitch, Itai
AU  - Danovitch I
AD  - Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical 
      Center, Los Angeles, CA, United States of America.
LA  - eng
SI  - ClinicalTrials.gov/NCT03688100
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210107
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antidepressive Agents)
SB  - IM
MH  - Aged
MH  - Antidepressive Agents/therapeutic use
MH  - Depression/*complications/drug therapy/psychology/*therapy
MH  - Disease Progression
MH  - Evidence-Based Medicine
MH  - Female
MH  - Heart Failure/*complications/psychology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Precision Medicine
MH  - Psychotherapy
MH  - Quality of Life
PMC - PMC7790529
COIS- The authors have declared that no competing interests exist.
EDAT- 2021/01/08 06:00
MHDA- 2021/04/24 06:00
PMCR- 2021/01/07
CRDT- 2021/01/07 20:19
PHST- 2020/07/12 00:00 [received]
PHST- 2020/12/08 00:00 [accepted]
PHST- 2021/01/07 20:19 [entrez]
PHST- 2021/01/08 06:00 [pubmed]
PHST- 2021/04/24 06:00 [medline]
PHST- 2021/01/07 00:00 [pmc-release]
AID - PONE-D-20-20277 [pii]
AID - 10.1371/journal.pone.0244453 [doi]
PST - epublish
SO  - PLoS One. 2021 Jan 7;16(1):e0244453. doi: 10.1371/journal.pone.0244453. 
      eCollection 2021.